Atomoxetine solution

Abstract

The present invention provides a novel palatable pharmaceutical composition in the form of aqueous solution of atomoxetine. The oral aqueous solution of this invention will significantly reduce the potently bitter taste of atomoxetine, and further avoid swallow issue for young and elderly patients.

We claim: 
     
       1. A pharmaceutical composition comprising 0.1-25 mg/mL atomoxetine, water, 1-30 mg/mL F-9999 PFC Artificial Raspberry CA Flavor, and a sweetening agent, wherein the pharmaceutical composition is in the form of a clear homogeneous oral aqueous solution, and the pH of the clear homogeneous oral aqueous solution is in the range of 2.0 to 6.0. 
     
     
       2. A method for treating attention-deficit/hyperactivity disorder (ADHD), comprising orally administering to a patient an effective amount of the pharmaceutical composition as claimed in  claim 1 . 
     
     
       3. The pharmaceutical composition as claimed in  claim 1 , wherein the concentration of atomoxetine is in the range of 3-6 mg/mL. 
     
     
       4. The pharmaceutical composition as claimed in  claim 3 , wherein the pH is in the range of 3.7-4.3. 
     
     
       5. The pharmaceutical composition as claimed in  claim 4 , wherein atomoxetine is atomoxetine hydrochloride. 
     
     
       6. The pharmaceutical composition as claimed in  claim 5 , further comprising sodium benzoate, sodium dihydrogen phosphate dihydrate, phosphoric acid, sorbitol solution, xylitol, and sucralose powder. 
     
     
       7. The pharmaceutical composition as claimed in  claim 6 , comprising 4.6 mg/mL atomoxetine hydrochloride, 0.8 mg/mL sodium benzoate, 17.0 mg/mL sodium dihydrogen phosphate dihydrate, 0.6 mg/mL phosphoric acid, 47.1 mg/mL sorbitol solution (70% w/w), 300.0 mg/mL xylitol, 14.7 mg/mL F-9999 PFC Artificial Raspberry CA Flavor, and 10.0 mg/mL sucralose powder.